Valicare knows the regulatory requirements for the validation of analytical methods
Analytical methods used during drug product manufacturing and quality control must be either compendial or validated methods. Analytical method validation (AMV) is a common worldwide regulatory requirement for pharmaceutical industry.
The leading document for method validation in Europe, North America and Asia is the guideline ICH Q2(R1) of the „International Committee of Harmonization“. Formal requirements for execution of validation are described herein and substantially exceed the system suitability test regularly used as daily measure to assure correct method results.
Valicare GmbH offers intensive educational training on the basics of AMV. In addition we offer to our customer topic related consultancy work and also documentation and method execution on request. A key competence of Valicare GmbH is the validation of bio-analytical methods. Development and installation of GMP-compliant analytical methods and method validation for manufacturing of medical devices complete the scope of services in this area.